EUCTR2007-001463-29-LT进行中（未招募）不适用
A Once-Daily Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment-Naïve Subjects
GlaxoSmithKline R&D Ltd0 个研究点目标入组 252 人开始时间: 2007年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Subjects with a documented diagnosis of T2DM and HbA1c =7.0% and =9.5% measured by the central laboratory at Visit 1 and Visit 2. Note: Subjects with HbA1c <7.5% must have a fasting fingerstick glucose ³7 mmol/L (126 mg/dL) at Week 0, prior to randomization. Note: The proportion of subjects who are randomized with an HbA1c <7.5% will be limited to be no more than 20% (approximately 51 subjects).
- •2. Subjects who are treatment-naïve, and have not taken insulin, or any oral or injectable anti-diabetic medication in the past 3 months and have not taken a glucose lowering agent for =4 weeks at any time in the past, or subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks
- •3. Subjects who are 18 to 70 years of age inclusive at the time of Screening.
- •4. Females of childbearing and non-childbearing and potential are eligible to participate as follows:
- •Women of childbearing potential must be willing to use one of the following contraception methods: intrauterine device, condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent for at least 30 days prior to the start of study medication, throughout the study and the follow-up visit. Note: use of oral contraceptives is not permitted.Women of non-child bearing potential are defined as follows: females regardless of age, with functioning ovaries who have a current documented tubal ligation, or who are surgically sterile (i.e. documented total hysterectomy or bilateral oophorectomy, or), or females who are post-menopausal.
- •All females must have a negative urine pregnancy test on the day of, and prior to randomization. Note: In questionable cases, a blood sample for follicle stimulating hormone (FSH) >40 MIU/mL and estradiol <40pg/mL (<140 pmol/L) may be obtained at screening, at the discretion of the investigator to confirm post-menopausal state.
- •5. Informed Consent: a signed and dated written consent must be obtained from the subject before any procedures are performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1.Metabolic Disease
- •Diagnosis of Type 1 diabetes mellitus.
- •History of ketoacidosis which has required hospitalization.
- •Thyroid disorder
- •TSH <0.4 MIU/L (<0.4 MCIU/mL) or >5.5 mIU/L (>5.5 MCIU/mL) at Screening.
- •Note: Hypothyroidism treated with the same dose and regimen of thyroid hormone replacement for at least 3 months prior to Screening is allowed.
- •BMI of <22 kg/m2 or >43 kg/m2.
- •Significant weight gain or loss (as defined as >5% of total body weight) in the 3 months prior to Screening
- •2.Diabetic Medication
- •Has taken insulin, or any oral or injectable anti-diabetic medication within 3 months of screening
- •Has taken insulin or any oral or injectable anti-diabetic medication =4 weeks at any time in the past
- •3.Cardiovascular Disease
- •Recent history or presence of clinically significant acute cardiovascular disease including:
- •Documented myocardial infarction in the 6 months prior to Screening.
- •Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either planned and/or occurred in the 6 months prior to Screening.
- •Unstable angina in the 6 months prior to Screening.
- •Clinically significant supraventricular arrhythmias requiring medical therapy, or history of nonsustained or sustained ventricular tachycardia. Symptomatic valvular heart disease or valvular heart disease requiring therapy other than endocarditis prophylaxis.
- •Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to IV) requiring pharmacologic treatment or the NYHA Class criteria in accordance with the local prescribing information for pioglitazone.
- •Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted antihypertensive therapy, then they must be on stable dose(s) of therapy for at least 4 weeks prior to Screening.
- •Based on local readings, the subject has an initial QTc interval (Bazett’s) =450msec at Screening, and after two additional ECGs taken 5 minutes apart, the average of the QTC interval from the three ECGs is =450msec.
- •Other clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of efficacy or safety data, or which otherwise contraindicates participation in a clinical trial with a new chemical entity.
- •Fasting triglycerides =400mg/dL (4.56mmol/L) at Screening. If a subject is receiving permitted lipid-lowering therapy, then they must be on a stable dose(s) of therapy for at least 6 weeks prior to Screening. Niacin and bile acid sequestrants are prohibited.
- •4.Hepatic Disease
- •Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody), or clinically significant hepatic enzyme elevation including:
- •Any one of the following enzymes greater than 2 times the upper limit of the reference range (ULRR) value at Screening.
- •alanine aminotransferase (ALT)
- •aspartate aminotransferase (AST)
- •alkaline phosphatase (AP)
- •Has a total bilirubin level that is >1.5 times the ULRR at Screening with the exception of suspected or confirmed Gilbert’s disease.
- •5.Pancreatic Disease
- •Secondary causes of diabetes:
- •history of chronic or acute pancreatitis
- •6.Renal Disease
- •Significant renal disease at Screening as manifested by:
- •lomerular filtration rate (GFR) <60mL/min (as calculated by Quest at Visit using the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR (mL/min/1.73m
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